CLINICAL TRIALS PROFILE FOR TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

All Clinical Trials for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01938417 ↗	Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute	Completed	University of Lausanne Hospitals		2006-10-01	This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).
NCT03308253 ↗	Study for Antibiotic Impregnated Calcium Sulfate Beads as Prophylaxis for Surgical Site Infection	Unknown status	McMaster University	Phase 4	2018-07-16	The CDC quotes a rate of wound infection of 2-5% for inpatient surgery. Patients undergoing a vascular operation, however, are generally at an increased risk of wound infection with rates often close to 5-10%. Groin incisions are an additional risk factor for surgical site infections, with rates of wound infection being quoted from 10-15%, and even as high as 30% in high risk patients. The use of implantable calcium sulfate beads mixed with antibiotics may help to lower the rate of infection in these high risk patients.
NCT04662632 ↗	Abbreviated Protocol for Two-Stage Exchange	Recruiting	Joint Purification Systems	Phase 2	2021-07-01	Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of PJI. Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life (QoL) and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
NCT04662632 ↗	Abbreviated Protocol for Two-Stage Exchange	Recruiting	Osteal Therapeutics, Inc.	Phase 2	2021-07-01	Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of PJI. Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life (QoL) and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
NCT05279586 ↗	Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients	Not yet recruiting	Madonna Magdy Fahmy	Early Phase 1	2022-03-01	The aim of this study is to compare the efficacy and safety of colistin versus lactulose for secondary prophylaxis of overt hepatic encephalopathy in patients with liver cirrhosis.
NCT05607030 ↗	A Second Trial of the Abbreviated Protocol Two-Stage Exchange	Not yet recruiting	Osteal Therapeutics, Inc.	Phase 2	2022-11-30	Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of PJI, absence of continued antiobiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, quality of life (QoL), and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.

Clinical Trial Conditions for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Orthopedic Operations	1
Prosthetic Joint Infection	1
Prosthetic-joint Infection	1
Surgical Site Infection	1

Condition MeSH

Condition MeSH for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Infections	3
Infection	2
Hepatic Encephalopathy	1
Brain Diseases	1

Clinical Trial Locations for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	12
Canada	1

Trials by US State

Trials by US State for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
Utah	1
Pennsylvania	1
Oklahoma	1
Ohio	1
North Carolina	1

Clinical Trial Progress for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Osteal Therapeutics, Inc.	2
Joint Purification Systems	1
Madonna Magdy Fahmy	1

Sponsor Type

Sponsor Type for TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Industry	3
Other	3

Tobramycin Sulfate in Sodium Chloride 0.9% (Plastic Container): Clinical Update, Market Analysis, and Projection

Last updated: May 10, 2026

What is the product and how is it positioned?

“Tobramycin sulfate in sodium chloride 0.9% in plastic container” is an injectable formulation of tobramycin (an aminoglycoside antibiotic) in 0.9% sodium chloride delivered in a plastic container. Commercial positioning is driven by:

• Hospital and institutional use for serious Gram-negative infections where aminoglycosides are indicated.
• Formulation-driven continuity of supply: plastic containers reduce glass fragmentation risk and support routine hospital handling workflows.
• Steady demand with periodic turnover from competitive tender cycles (hospital procurement).

Core therapeutic linkage (mechanism and class): tobramycin is used against susceptible organisms and is frequently combined with other agents in severe infections (class context for aminoglycosides).

What clinical trial signals exist for this specific formulation?

A formulation-level clinical-trials update is only defensible when the trials are explicitly tied to the same drug substance and the same dosage form/packaging (tobramycin sulfate in 0.9% sodium chloride, plastic container) and are reported in registries with matching product identifiers. In the available dataset context for this request, no formulation-specific, registry-distinct clinical trials tied to this exact packaging configuration can be stated as “current,” “ongoing,” or “readout” without risking factual mismatch.

Is there a patent or exclusivity timeline that blocks or enables generic/brand entries?

A reliable exclusivity or patent-position assessment for this exact presentation requires product-level patent mapping and exclusivity attribution (for example, Orange Book entry specific to the presentation and container). In this request context, no presentation-specific patent or exclusivity dataset is available to ground a correct timeline, so no defensible barrier or generic runway can be quantified.

What is the market footprint by segment?

The market for injectable tobramycin is segmented primarily by:

• Care setting: hospitals, long-term acute care, and specialist centers.
• Use case: severe Gram-negative infections, including respiratory infections in specific patient populations (where local guidelines support aminoglycosides).
• Procurement model: competitive hospital contracts where unit cost, availability, and supply reliability dominate.

Formulation and container effects on procurement Plastic-container supply is often treated as a handling and logistics improvement rather than a clinical differentiator. In tender evaluations, purchasing teams typically weight:

• Availability and lead-time (pharmacy stocking risk)
• Price per dose
• Container fit for compounding and administration workflows
• Consistency across batch releases

Where do demand drivers come from?

Key drivers for tobramycin injections and similar aminoglycoside regimens include:

• Baseline incidence of serious bacterial infections requiring IV antibiotics.
• Antibiotic stewardship patterns that can increase or decrease aminoglycoside use depending on resistance trends and guideline updates.
• Shift in hospital formulary preferences based on local resistance and clinical outcomes.

What are the risks to volume growth?

Growth is typically constrained by:

• Therapy substitution: hospitals may shift to alternative Gram-negative agents when stewardship guidance favors other classes.
• Safety monitoring burden (aminoglycoside nephrotoxicity and ototoxicity monitoring drives protocol adherence and may cap use).
• Regulatory or quality disruptions in supply chains that can temporarily reduce availability.

How should investors model price vs. volume?

For injectable antibiotics, a practical projection model typically decomposes:

• Volume into tender-driven uptake and refill cadence
• Net price into mix shifts across brands/generics and contract renegotiations
• Gross margin into inventory and competitive pricing pressure

Given no presentation-specific patent and no formulation-specific clinical-trials readouts are available here, the only defensible approach is a scenario-neutral market projection structure rather than a numbered forecast.

Market projection framework (what to forecast and how)

Use three layers to avoid mixing generic-cycle effects with clinical efficacy updates:

1) Forecast base demand (units)

• Anchor to the hospital antibiotic usage baseline for aminoglycoside-containing regimens.
• Apply an institutional retention factor based on formulary stability and stewardship inertia.
• Apply tender churn adjustments: when contracts re-bid, volume can shift between suppliers even if total class demand stays flat.

2) Model net price (contracted)

• Assume downward pressure typical of injectable antibiotics once multiple suppliers are established.
• Incorporate intermittent price spikes when supply constraints hit.

3) Translate to revenue (net sales)

• Revenue = Units delivered x Net price per unit.
• Track mix between brands/generics and between package sizes (if applicable).

What is the likely competitive landscape?

This product presentation typically competes in a field where:

• Multiple generic manufacturers may supply the same active with equivalent dosing and comparable administration requirements.
• Differentiation is less about clinical outcomes and more about:
  • Supply reliability
  • Distribution coverage
  • Contract pricing and rebate structures
  • Packaging acceptability to hospital systems

What near-term business implications follow from the evidence constraints?

Because formulation-specific trial readouts and presentation-specific exclusivity/patent data cannot be supported in this response, the actionable implications are restricted to commercial mechanics:

• Near-term growth is contract- and supply-driven, not trial-driven.
• Sustainability depends on distribution performance and tender competitiveness.
• Investment focus should be on supply-chain strength and pricing execution, not on claiming clinical differentiation.

Key Takeaways

• The product is an IV tobramycin antibiotic formulation in 0.9% sodium chloride in plastic container, positioned for hospital/institutional use.
• A formulation-specific clinical trials update and a presentation-specific exclusivity/patent timeline cannot be stated from the available evidence within this request context.
• Market behavior for injectable antibiotics is dominated by hospital procurement cycles, supply reliability, and net price pressure rather than new clinical differentiation.
• Revenue projections should be modeled via units (tender retention and churn), net price (contract dynamics), and mix (brand vs generic), not via formulation-level clinical trial assumptions.
• Competitive strategy should prioritize contract execution and supply continuity.

FAQs

1. Is there a confirmed active clinical trial pipeline for this exact plastic-container formulation?
   No formulation-specific, registry-distinct current pipeline can be stated here.

2. What drives demand for tobramycin IV products in hospitals?
   Serious Gram-negative infection treatment needs, stewardship patterns, and institutional formulary decisions.

3. Does the plastic container meaningfully change clinical outcomes?
   It typically changes handling and logistics more than clinical endpoints; procurement uses it for practical workflow fit.

4. What is the main threat to revenue growth for this presentation?
   Tender re-bids, competitive generic pricing, and antibiotic substitution within formularies.

5. How should a forecast be structured without relying on trial events?
   Separate unit volume drivers (contract retention and churn) from net price drivers (contract dynamics), then apply mix effects.

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References

[1] FDA Orange Book. Drug Products @ FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ClinicalTrials.gov. Tobramycin studies and related entries. https://clinicaltrials.gov/